Search

Introduction Bone conduction implants, responsible for transmitting sound from an external processor to the inner ear, can be divided into active and passive, depending on the vibratory stimulus location. The use of transcutaneous device has increased, given its aesthetic appeal, the complications and limitations of percutaneous devices, and patient's treatment adherence, focusing mainly on efficacy. However, various complications are associated with the use of transcutaneous prosthesis, which can often be serious. Objective To approach the literature on complications involving transcutaneous bone-anchored prostheses through a systematic review of articles published in the past 10 years (2011–2021). Data Synthesis The MEDLINE, EMBASE, Scopus, and Cochrane Library databases were searched. All articles written in English reporting on currently available transcutaneous prosthesis implantation and its complications were selected. Studies on both children and adults were included. The data on complications were extracted, and complications were classified as minor or major and associated to each device used. Thirty-seven articles were included in the study, of which 14 were prospective cohort studies, 22 were retrospective case series, and 1 was a case report. Most studies (18) included both adults and children. Moreover, 901 implantations were performed, of which 552 implanted Baha Attract (Cochlear Ltd., Sydney, Australia), 244 implanted BoneBridge (MED-EL, Innsbruck, Austria), and 105 implanted Sophono (Sophono Inc., Boulder, CO, USA]). Furthermore, 192 adverse events were reported (total complication rate, 21.3%), with 161 minor complications (84.3%) and 31 major complications (16.1%). Conclusion Transcutaneous prosthesis is an audiological alternative with fewer complications than percutaneous prosthesis. However, its indication should be judicious because complications are common, and although most complications are minor, serious infections requiring explantation may develop.

The Bonebridge implant can be a satisfactory solution for patients with conductive or mixed hearing loss (CHL or MHL), or with single-sided deafness (SSD). The aim of the study was to assess patients’ self-reported benefits with the Bonebridge and characterize the relationships between pre-implantation audiometric data, auditory functioning, and satisfaction after implantation. A focus was to see whether different types of hearing loss were associated with particular benefits. The study sample consisted of 81 patients. Procedures comprised pure tone audiometry before implantation, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and a structured interview asking about satisfaction. Statistically significant improvements after implantation were found in all groups (CHL, MHL, SSD) on the APHAB questionnaire. In the structured interview, patients with SSD were the least satisfied. No significant correlation was found between pre-operative air-bone gap and bone conduction thresholds or with APHAB score. Bonebridge implantation is beneficial to patients with CHL or MHL, or with SSD. Assessment of patients for Bonebridge implantation is complex, and audiometric data should be complemented by patient-reported outcomes to provide deeper insight into their individual needs and attitudes.

Background The BONEBRIDGE (MED-EL, Innsbruck, Austria) is a bone-conduction implant used in the treatment of conductive and mixed hearing loss. The BONEBRIDGE consists of an external audio processor and a bone-conduction floating mass transducer that is surgically implanted into the skull in either the transmastoid, retrosigmoid or middle fossa regions. The manufacturer includes self-tapping screws to secure the transducer; however, self-drilling screws have also been used with success. In cases where the skull is not thick enough to house the transducer, lifts are available in a variety of sizes to elevate the transducer away from the skull. The objective of the present study was to investigate the effects of screw type, lift thickness, and implant location on the sound transmission of the BONEBRIDGE. Method Six cadaveric temporal bones were embalmed and dried for use in this study. In each sample, a hole was drilled in each of the three implant locations to house the implant transducer. At the middle fossa, six pairs of screw holes were pre-drilled; four pairs to be used with self-tapping screws and lifts (1, 2, 3, and 4 mm thick lifts, respectively), one pair with self-tapping screws and no lifts, and one pair with self-drilling screws and no lifts. At the transmastoid and retrosigmoid locations, one pair of screw holes were pre-drilled in each for the use of the self-tapping screws. The vibration of transmitted sound to the cochlea was measured using a laser Doppler vibrometry technique. The measurements were performed on the cochlear promontory at eight discrete frequencies (0.5, 0.75, 1, 1.5, 2, 3, 4 and 6 kHz). Vibration velocity of the cochlear wall was measured in all samples. Measurements were analyzed using a single-factor ANOVA to investigate the effect of each modification. Results No significant differences were found related to either screw type, lift thickness, or implant location. Conclusions This is the first known study to evaluate the effect of screw type, lift thickness, and implant location on the sound transmission produced by the BONEBRIDGE bone-conduction implant. Further studies may benefit from analysis using fresh cadaveric samples or in-vivo measurements.

Objective: To assess the performance of an active transcutaneous implantable-bone conduction device (TI-BCD), and to evaluate the benefit of device digital signal processing (DSP) features in challenging listening environments. Design: Participants were tested at 1- and 3-month post-activation of the TI-BCD. At each session, aided and unaided phoneme perception was assessed using the Ling-6 test. Speech reception thresholds (SRTs) and quality ratings of speech and music samples were collected in noisy and reverberant environments, with and without the DSP features. Self-assessment of the device performance was obtained using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. Study sample: Six adults with conductive or mixed hearing loss. Results: Average SRTs were 2.9 and 12.3 dB in low and high reverberation environments, respectively, which improved to −1.7 and 8.7 dB, respectively with the DSP features. In addition, speech quality ratings improved by 23 points with the DSP features when averaged across all environmental conditions. Improvement scores on APHAB scales revealed a statistically significant aided benefit. Conclusions: Noise and reverberation significantly impacted speech recognition performance and perceived sound quality. DSP features (directional microphone processing and adaptive noise reduction) significantly enhanced subjects’ performance in these challenging listening environments.

The retrosigmoidal (RS) placement of the Bonebridge system (BB) has been advocated for cases of unfavourable anatomical or clinical conditions which contraindicate transmastoid-presigmoidal positioning. However, these disadvantageous conditions, combined with the considerable dimensions of the implant, may represent a challenge, especially for surgeons with no skull base experience. Moreover, the literature reports only limited experience concerning RS implantation of the BB system.A multicentre, retrospective study was conducted to analyse the surgical and functional outcomes of a wide population of patients undergoing RS placement of the BB system by means of a surgical technique specifically developed to overcome the intraoperative issues related to this surgery. Twenty patients with conductive or mixed hearing loss and single sided deafness were submitted to RS implantation of the BB system.Audiological assessment concerning the measurement of the functional and effective gain by pure-tone audiometry (28 dB HL and -12.25 dB HL, respectively) and speech audiometry (24.7 dB HL and -21 dB HL, respectively) was conducted. A high overall subjective improvement of quality of life was recorded with the Glasgow Benefit Inventory questionnaire. No major complications, such as device extrusions or other conditions requiring revision surgery, were reported during the follow-up period (median: 42 months).In our study, which has one of the largest cohort of patients reported in the literature, RS placement of the BB system was safe and effective. Our functional results showed comparable hearing outcomes with presigmoidal placement. The effective gain, rarely investigated in this field, may be the object of further research to improve our understanding of bone conduction mechanisms exploited by bone conduction hearing implants.Posizionamento retrosigmoideo di una protesi transcutanea attiva a conduzione ossea: prospettive chirurgiche e audiologiche in uno studio multicentrico.Il posizionamento retrosigmoideo del sistema Bonebridge (BB) è stato introdotto per ovviare alla presenza di condizioni anatomiche e cliniche che controindichino l’alloggiamento del device in regione presigmoidea. Tuttavia, queste condizioni sfavorevoli, associate alle considerevoli dimensioni dell’impianto, possono costituire un ostacolo per i chirurghi senza esperienza nell’ambito del basi-cranio. Inoltre, in letteratura sono pochi gli studi riguardanti il posizionamento retrosigmoideo del sistema BB.Abbiamo svolto uno studio retrospettivo e multicentrico con lo scopo di analizzare i risultati chirurgici e funzionali di un’ampia popolazione di pazienti sottoposti a posizionamento retrosigmoideo del sistema BB tramite una specifica tecnica chirurgica che è stata sviluppata con lo scopo di superare i problemi intraoperatori relativi a questa chirurgia. Venti pazienti con ipoacusia di trasmissione o mista e affetti da sordità monolaterale sono stati sottoposti a impianto retrosigmoideo del sistema BB.La valutazione audiologica ha riguardato la misurazione del guadagno funzionale ed effettivo in audiometria tonale (rispettivamente pari a 28 dB HL e -12.25 dB HL) e audiometria vocale (rispettivamente pari a 24.7 dB HL e -21 dB HL). Globalmente è stato riportato un significativo miglioramento soggettivo della qualità della vita rispetto alla condizione preoperatoria, quantificato mediante la compilazione del questionario Glasgow Benefit Inventory. Non sono state riscontrate gravi complicanze o condizioni necessitanti una chirurgia di revisione durante il periodo di follow-up (mediana: 42 mesi).Nell’ambito della nostra esperienza, risultata tra le più ampie mai riportate in letteratura, il posizionamento retrosigmoideo del sistema BB si è dimostrato sicuro ed efficace. I nostri risultati funzionali hanno mostrato dati uditivi comparabili con il posizionamento presigmoideo. Il guadagno effettivo, raramente indagato in questo campo della letteratura, potrebbe essere oggetto di future ricerche al fine di migliorare la nostra comprensione dei meccanismi di conduzione ossea impiegati da questa tipologia di protesi impiantabili.

The aim of this letter is to respond to a commentary on a published article on the middle fossa approach to BONEBRIDGE implantation with self-drilling screws published by the senior authors.

Objectives : To investigate the effectiveness of a bone-anchored hearing implant system (Bonebridge implant technology) as a rehabilitation treatment for individuals with conductive or mixed hearing losses. Methods : This is a retrospective cohort study. Twelve implanted ears with conductive or mixed hearing losses were implanted with this device at a tertiary university hospital between 2012 and 2016. Audiological tests included pure tone air conduction (AC) and bone conduction (BC) measurements and unaided and aided sound-field thresholds. To evaluate the speech intelligibility in a quiet environment, the speech discrimination score (SDS) was tested using Arabic monosyllabic words, and the speech reception threshold (SRT) was measured using Arabic disyllabic words spoken in front of them. The subjective sound quality was assessed with the Hearing Implant Sound Quality Index (HISQUI). Results : In comparison with the unaided condition, there was a significant improvement in the aided thresholds, SDS, and SRT. Comparing the aided and unaided thresholds, the average AC threshold improved with an average functional gain of 40±6.3dB. The unaided SRT improved from 72.5 dB hearing levels (HL)(median) to 27.5 dB HL (median) when aided, and patients performed 71% better, on average, based on the SDS with the help of the device. The HISQUI questionnaire revealed high satisfaction with the device sound quality. Conclusion : Patients with conductive and mixed hearing loss substantially benefit from the Bonebridge active transcutaneous BC hearing implant.

Background Bone conduction implants can be used in the treatment of conductive or mixed hearing loss. The BONEBRIDGE bone conduction implant (BB-BCI) is an active, transcutaneous device. BB-BCI implantation can be performed through either the transmastoid or retrosigmoid approach with their respective limitations. Here, we present a third, novel approach for BB-BCI implantation. Objective Describe the detailed surgical technique of BB-BCI implantation through a middle fossa approach with self-drilling screws and present preliminary audiometric outcome data following this approach. Methods A single institution, retrospective chart review was completed for patients implanted with the BB-BCI via the middle fossa approach. Preoperative planning and modelling were performed using 3D Slicer. Audiological testing was performed pre- and post-operatively following standard audiometric techniques. Results Forty patients underwent BB-BCI implantation using the middle fossa approach. Modelling techniques allowed for implantation through the use of external landmarks, obviating the need for intraoperative image guidance. The surgical technique was refined over time through experience and adaptation. Mean follow-up was 29 months (range 3–71 months) with no surgical complications, favourable cosmesis, and expected audiometric outcomes. An average functional gain of 39.6 dB (± 14.7 SD) was found. Conclusion The middle fossa technique with self-drilling screws is a safe and effective option for BONEBRIDGE implantation. As a reference for other groups considering this approach, an annotated video has been included as a supplement to the study. Electronic supplementary material The online version of this article (10.1186/s40463-019-0354-7) contains supplementary material, which is available to authorized users.

Background: With the Bonebridge, a new bone-anchored hearing aid has been available since March 2012. The objective of the study was to analyse the visualisation of the implant itself as well as its impact on the representation of the bony structures of the petrosal bone in CT, MRI and cone beam CT (CBCT). Methods: The Bonebridge was implanted unilaterally in two completely prepared human heads. The radiological imaging by means of CBCT, 64-slice CT, 1.5-T and 3.0-T MRI was conducted both preoperatively and postoperatively. The images were subsequently evaluated from both the ENT medical and nd radiological perspectives. Results: As anticipated, no visualisation of the implant or of the petrosal bones could be realised on MRI because of the interactive technology and the magnet artefact. In contrast, an excellent evaluability of the implant itself as well as of the surrounding neurovascular structures (sinus sigmoideus, skull base, middle ear, inner ear, inner auditory canal) was exhibited in both the CT and in the CBCT. Conclusion: The Bonebridge can be excellently imaged with the radiological imaging technologies of CT and CBCT. In the process, CBCT shows discrete advantages in comparison with CT. No relevant restrictions in image quality in the evaluation of the bony structures of the petrosal bones could be seen.

The Bonebridge(®) (BB) transcutaneous bone conductive implant (BCI) may overcome some of the issues related to a percutaneous BCI, such as management of the external screw, delayed activation or possible skin complications. Moreover, it has been shown to enable a functional outcome similar to percutaneous BCI in both conductive and mixed types of hearing loss.To obtain clinical data from a preliminary series of patients implanted with a new transcutaneous BCI.Four subjects affected by conductive/mixed hearing loss underwent implantation of the BB by two approaches: the transmastoid, presigmoid approach and the retrosigmoid approach. Soundfield thresholds were assessed with warble tones in a soundproof audiometric booth, and word recognition scores (WRSs) as speech reception thresholds (SRTs) were used to compare the unaided versus the post-implantation condition.The surgical procedure was completed in all cases, with only minor intraoperative divergence from the CT-based planning and no postoperative complications. The average improvement of the SRT in quiet with the BB in comparison to the unaided condition was 36.25 dB. All the implanted subjects reached SRT values below 65 dB, indicating a better understanding in quiet, with 100% word recognition.